Lee Medical International instituted a voluntary Class I recall of custom dialysis kits manufactured between Jan. 13 and March 21, due to a component that may not be sterile and could cause serious or life-threatening infection.
The kits were designed to include all components—gloves, bandages, fistula needles, antibacterial pads and specific bloodlines—used in preparing hemodialysis vascular access sites for patients undergoing dialysis procedures. The antibacterial pads—Povidone Iodine Prep Pads—were recalled by Hartland, Wis., manufacturer H &P Industries. Customers were notified March 22 by email and telephone, according to a release from the FDA.
The pads are used to prevent infection in minor cuts, scrapes and burns and are labeled as an antiseptic for preparation of the skin prior to surgery. Affected H &P pads can be identified by their packaging as follows: Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety and Total Resources.
Click here for the FDA release.